Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
- Registration Number
- NCT02776917
- Lead Sponsor
- Barbara Parker, MD
- Brief Summary
This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called receptor-tyrosine-kinase like orphan receptor 1 (ROR1) on the surface of breast cancer cells. Cirmtuzumab blocks the growth and survival of the breast cancer cells in laboratory tests. ROR1 is rarely expressed on healthy cells. Cirmtuzumab is considered experimental and is not approved by United States (U.S.) Food and Drug Administration (FDA).
- Detailed Description
* This is a phase 1b, open-label, non-randomized, fixed dose study in patients with HER2 negative metastatic, or locally advanced, unresectable breast cancer.
* Cirmtuzumab and paclitaxel will be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity, as long as the subject is tolerating the drug and does not exhibit disease progression.
* Blood and tissue samples will be collected at pre-specified times to enable pharmacokinetic and correlative studies.
* Adverse events (AE) will be monitored throughout the trial. Reporting of AEs will be in accordance with CTCAE version 4.03.
* Assessment of tumor response will be performed by physical examination and/or by radiographic imaging and according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
* Patients will be assessed at 28 days following the last dose of cirmtuzumab to assess tumor response and at 56 days following the last dose of cirmtuzumab to assess any adverse events and to document any concomitant cancer therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cirmtuzumab + Paclitaxel Cirmtuzumab + Paclitaxel Cirmtuzumab 600 mg is administered intravenously on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. Paclitaxel 80 mg/m\^2 is administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle.
- Primary Outcome Measures
Name Time Method The rate of dose-limiting toxicities during the first 4 weeks of treatment Within 4 weeks of starting study treatment The proportion of clinically significant adverse events per CTCAE Version 4.03 at least possibly related to cirmtuzumab or the combination of cirmtuzumab and paclitaxel during the first four weeks of investigational treatment.
- Secondary Outcome Measures
Name Time Method Objective tumor response rate 9 months The proportion of patients with complete and partial tumor responses as assessed by RECIST v1.1
Best tumor response rate 9 months The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1
Time to progression 2 years The duration of response measured from the time of initial response until documented tumor progression.
Safety and tolerability of the combination therapy since the start of any study treatment. 12 months Treatment-emergent adverse events beginning from the start of study treatment to six months after study treatment completion.
Measurement of ROR1 expression levels and cancer stem cell populations 12 months Immunohistochemistry measurement of ROR1 expression levels and other cancer stem cell markers (ALDH, CD133) from primary pre-treatment and post-treatment tumor specimens.
Trial Locations
- Locations (1)
University of California, San Diego
🇺🇸La Jolla, California, United States